CholecystectomyNESTNCT06473688
The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)
An observational study of Cholecystectomy, run by Distalmotion SA at 4 sites in 3 countries.
Trial summary
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Jun 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing a cholecystectomy.
Who may be able to join
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.
Who cannot join
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
- Patients with pacemakers or internal defibrillators
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- Any planned concomitant procedures
- Patient deprived of liberty by administrative or judicial decision
- Participation in another interventional clinical trial
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Switzerland2 sites
Kantonsspital Winterthur
Winterthur, 8401
Klinik Hirslanden Zürich
Zurich, 8032
About this study
Official title: The DEXTER-assisted Non-emergent and Acute Cholecystectomy Study
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.
- Conditions
- Cholecystectomy
- Being tested
- Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Robotic-assisted and laparoscopic cholecystectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
primary safety endpoint
occurrence of Clavien - Dindo grades III-V adverse events
Measured: up to 30 days
primary performance endpoint
successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start21 Jun 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Confinis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473688
- Sponsor's protocol ID
- 2024-02
- Acronym
- NEST
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DEXTER-assisted Non-emergent and Acute Cholecystectomy Study
- ClinicalTrials.gov ID
- NCT06473688
- Acronym / sponsor ID
- NEST / 2024-02
- Conditions
- Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Collaborators
- Confinis
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing a cholecystectomy.
Key inclusion criteria (2 listed)
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.
Key exclusion criteria (9 listed)
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecystectomyRobotic-assisted and laparoscopic cholecystectomy | Procedure or surgery | – |
Primary outcome
primary safety endpoint
Time frame: up to 30 days
occurrence of Clavien - Dindo grades III-V adverse events
primary performance endpoint
Time frame: intraoperative
successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by Distalmotion SA at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary safety endpoint (time frame: up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.